ISO 18615:2020

Overview

ISO 18615:2020 outlines the general requirements for electric radial pulse tonometric devices used in traditional Chinese medicine (TCM). This standard provides a framework for the design, manufacture, and performance of these devices, ensuring they meet safety and efficacy criteria. The standard is essential for manufacturers, healthcare providers, and regulatory bodies involved in the development and application of TCM technologies.

Key Requirements

The standard specifies several critical requirements that must be addressed to ensure compliance:

• Device Design: Devices must be designed to accurately measure radial pulse parameters, ensuring reliability and consistency in readings.
• Safety Standards: Compliance with electrical safety standards is mandatory, including protection against electrical shock and mechanical hazards.
• Performance Testing: Devices must undergo rigorous performance testing to validate their accuracy and repeatability in various clinical settings.
• Calibration Procedures: Clear guidelines for calibration must be established to maintain the accuracy of measurements over time.
• User Instructions: Comprehensive user manuals must be provided, detailing operation, maintenance, and troubleshooting procedures.

Implementation Benefits

Adhering to ISO 18615:2020 offers numerous benefits for manufacturers and healthcare practitioners:

• Enhanced Patient Safety: By complying with safety standards, manufacturers can reduce the risk of device-related injuries.
• Improved Device Reliability: Rigorous performance testing ensures that devices provide accurate and consistent measurements, leading to better patient outcomes.
• Market Access: Compliance with this standard can facilitate entry into regulated markets, as it demonstrates adherence to internationally recognised quality benchmarks.
• Informed Decision-Making: Healthcare providers can rely on standardised measurements to make informed clinical decisions, enhancing the quality of care.

Compliance Value

Compliance with ISO 18615:2020 not only ensures that devices meet essential safety and performance criteria but also enhances the credibility of manufacturers in the healthcare market. Regulatory bodies often require compliance with recognised standards as part of the approval process for medical devices. By adhering to this standard, manufacturers can:

• Build Trust: Demonstrating compliance fosters trust among healthcare providers and patients, as it assures them of the device's quality and reliability.
• Reduce Liability Risks: Compliance can mitigate legal risks associated with device failures or safety issues, protecting manufacturers from potential lawsuits.
• Facilitate Quality Management: Implementing the standard encourages a culture of quality within organisations, leading to continuous improvement in product development and patient care.

In summary, ISO 18615:2020 is a vital standard for electric radial pulse tonometric devices in traditional Chinese medicine. Its comprehensive requirements not only ensure device safety and efficacy but also provide significant compliance benefits that enhance patient care and market competitiveness.